BEUDAMED
    FDA Adverse Event Other Summary report: N

    VV SKY NAVIGATION PLATFORM; BRAINSUITE NET

    MDR report key: 1080321 · Received July 18, 2008

    Report

    Report Number
    8043933-2008-00003
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO EVENT, ACCORDINGLY NO PATIENT OR USER INJURY REPORTED. HOWEVER A RISK TO USER HEALTH COULD NOT BE EXCLUDED. SUMMARY OF EVALUATION: THIS POTENTIAL PROBLEM WAS DETECTED BY BRAINLAB INTERNALLY BY EVALUATION OF THE DEVICE DESIGN. CORRECTIVE AND PREVENTIVE ACTION: PRODUCT NOTIFICATION - EXISTING VECTORVISION SKY AND/OR BRAINSUITE NET CUSTOMERS WILL RECEIVE A PRODUCT NOTIFICATION INFORMATION. ALL VECTORVISION SKY AND/OR BRAINSUITE NET CUSTOMERS WILL BE VISITED TO IMPLEMENT A HARDWARE UPDATE IN ORDER TO INCREASE THE STANDARD OF ELECTRICAL SAFETY.

    Description of Event or Problem · 1

    UNDER SPECIAL CIRCUMSTANCES, THE MAINS INPUT WIRING OF THE MEDICAL POWER SUPPLY INSIDE THE RACK (OUTSIDE THE OR) OF THE BRAINLAB VECTORVISION SKY AND/OR BRAINSUITE NET COULD BE UNINTENTIONALLY TOUCHED BY THE USER. IF THIS OCCURS WITH THE MEDICAL POWER SUPPLY CONNECTED TO MAIN POWER, THIS CAN POTENTIALLY LEAD TO AN ELECTRICAL SHOCK. THE MEDICAL POWER SUPPLY IS LOCATED INSIDE A RACK WITH GLASS DOORS OUTSIDE THE OR. INSIDE THAT RACK, THE MEDICAL POWER SUPPLY IS LOCATED BEHIND COVER PLATES. THE POTENTIAL RISK FROM LAB'S INVESTIGATION WAS CONCLUDED IN 2008. THERE HAS BEEN NO EVENT, PATIENT OR USER INJURY REPORTED BY ANY HOSPITAL. HOWEVER A RISK TO USER HEALTH COULD NOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VV SKY NAVIGATION PLATFORM; BRAINSUITE NET NONE MUJ BRAINLAB AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1